US2025099745A1PendingUtilityA1

Percutaneous blood pump with outflow blocking sleeve

Assignee: BOSTON SCIENT SCIMED INCPriority: Sep 25, 2023Filed: Sep 24, 2024Published: Mar 27, 2025
Est. expirySep 25, 2043(~17.1 yrs left)· nominal 20-yr term from priority
Inventors:Qian Liu
A61M 60/865A61M 60/13A61M 60/416A61M 60/226A61M 60/221A61M 60/833
67
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Claims

Abstract

An outflow blocking sleeve removably surrounding a blood outlet of a percutaneous blood pump positioned at a distal end of a catheter. The outflow blocking sleeve is configured to prevent blood egress from the blood outlet during insertion of the blood pump into a vasculature at a vascular access site. The blood pump is sized to be passed distally through an elastomeric seal of an introducer sheath into a lumen of an elongate shaft of the introducer sheath while the outflow blocking sleeve is prevented from passing through the elastomeric seal during advancement of the blood pump through the elastomeric seal.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system, comprising:
 an introducer sheath including a hub, an elongate shaft extending distally from the hub, and an elastomeric seal positioned in the hub;   a catheter including an elongate shaft and a percutaneous blood pump positioned at a distal end of the elongate shaft, the percutaneous blood pump including a blood inlet, a blood outlet, and an impeller assembly positioned therebetween to pump blood from the blood inlet to the blood outlet during use; and   an outflow blocking sleeve removably surrounding the blood outlet;   wherein the blood pump is sized to be passed distally through the elastomeric seal into a lumen of the elongate shaft of the introducer sheath while the outflow blocking sleeve is prevented from passing through the elastomeric seal during advancement of the blood pump through the elastomeric seal.   
     
     
         2 . The system of  claim 1 , wherein the outflow blocking sleeve includes a distal end region having an inner diameter and a proximal end region having a reduced inner diameter less than the inner diameter of the distal end region. 
     
     
         3 . The system of  claim 2 , wherein the distal end region tightly surrounds the blood outlet to occlude blood flow therefrom and the proximal end region extends over a distal portion of the elongate shaft of the catheter. 
     
     
         4 . The system of  claim 1 , wherein the outflow blocking sleeve has a length of 7 cm or less. 
     
     
         5 . The system of  claim 1 , further comprising a guidewire extending out of an outflow window of the blood outlet and extending proximally therefrom along an exterior of the blood pump. 
     
     
         6 . The system of  claim 5 , wherein the outflow blocking sleeve surrounds the guidewire extending along the exterior of the blood pump. 
     
     
         7 . The system of  claim 1 , wherein the outflow blocking sleeve includes a preferential separation line extending along a length of the outflow blocking sleeve. 
     
     
         8 . The system of  claim 1 , wherein the outflow blocking sleeve includes a strip of material configured to separate from a tubular wall of the outflow blocking sleeve when pulled. 
     
     
         9 . The system of  claim 1 , wherein the outflow blocking sleeve includes a flared distal end configured to abut a proximal face of the elastomeric sleeve. 
     
     
         10 . The system of  claim 1 , wherein the outflow blocking sleeve includes a bulbous distal end configured to abut a proximal face of the elastomeric sleeve. 
     
     
         11 . A system, comprising:
 a catheter including an elongate shaft and a percutaneous blood pump positioned at a distal end of the elongate shaft, the percutaneous blood pump including a blood inlet, a blood outlet, an impeller positioned therebetween to pump blood from the blood inlet to the blood outlet during use, and a motor housing positioned proximal of the impeller, the motor housing including a motor to rotationally drive the impeller; and   an outflow blocking sleeve tightly surrounding the blood outlet and extending proximally therefrom to surround the motor housing;   wherein the outflow blocking sleeve is configured to prevent blood egress from the blood outlet during advancement of the blood pump into a vasculature at a vascular access site.   
     
     
         12 . The system of  claim 11 , wherein the outflow blocking sleeve includes a distal end region having an inner diameter and a proximal end region having a reduced inner diameter less than the inner diameter of the distal end region. 
     
     
         13 . The system of  claim 12 , wherein the distal end region tightly surrounds the blood outlet to occlude blood flow therefrom and the proximal end region extends over a distal portion of the elongate shaft of the catheter proximal of the motor housing. 
     
     
         14 . The system of  claim 11 , wherein the outflow blocking sleeve has a length of 7 cm or less. 
     
     
         15 . The system of  claim 11 , further comprising a guidewire extending out of an outflow window of the blood outlet and extending proximally therefrom along an exterior of the motor housing, wherein the outflow blocking sleeve surrounds the guidewire extending along the exterior of the motor housing. 
     
     
         16 . A method of percutaneously inserting a blood pump into a vasculature at a vascular access site, the method including:
 advancing a catheter, including the blood pump positioned at a distal end of an elongate shaft of the catheter, into an introducer sheath having an elastomeric seal, the blood pump including a blood inlet, a blood outlet, and an impeller assembly positioned therebetween to pump blood from the blood inlet to the blood outlet during use,   advancing the blood pump through the elastomeric seal while an outflow blocking sleeve occludes the blood outlet when the blood outlet is located proximal of the elastomeric seal and the blood inlet is located distal of the elastomeric seal such that blood egress from the blood outlet is prevented; and   further advancing the blood pump through the elastomeric seal while the outflow blocking sleeve abuts a proximal face of the elastomeric sleeve and remains exterior of the elastomeric seal such that the blood outlet passes through the elastomeric seal to a location distal of the elastomeric seal.   
     
     
         17 . The method of  claim 16 , wherein the blood pump is advanced over a guidewire extending out of an outflow window of the blood outlet and the guidewire extends proximally therefrom along an exterior of the blood pump. 
     
     
         18 . The method of  claim 17 , wherein the outflow blocking sleeve surrounds the guidewire extending along the exterior of the blood pump. 
     
     
         19 . The method of  claim 16 , further comprising laterally removing the outflow blocking sleeve from the catheter after the blood outlet of the blood pump is advanced to a location distal of the elastomeric seal. 
     
     
         20 . The method of  claim 19 , wherein the outflow blocking sleeve is splittable along its length to separate the outflow blocking sleeve from the catheter.

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